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临床试验/NCT02731196
NCT02731196已完成不适用

Comparison of Early Exercise Intervention Versus Late Exercise Intervention on Pain and Neurodynamic Mobility Following Unilateral Lumbar Microdiscectomy: A Randomized Controlled Trial

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Numeric Pain Rating Scale

研究概览

简要总结

Low back pain is common, costly and affecting up to 80% of the population with the lumbar discectomy being a frequent spinal procedure for disc herniations. Pain & mobility impairments persist in patients following microdiscectomy with long term issues of back pain. The question remains as to why some patients recover quickly and without lasting difficulties while other patients persist with prolonged disability following the same surgery. The purpose of this study is to determine how to guide the patient towards full function and evaluate the timing to initiate strengthening, neurodynamics and a walking exercise program.

详细描述

The direction of treatment for low back pain both surgically and conservatively seeks to improve function in both daily and sporting activities for all patients. The patients continuing to suffer from a significant level of pain, disability and reduced function following single level microdiscectomy may benefit from a multi-factorial approach. A reduction in neurodynamic mobility related to dural adhesions is considered to be a contributing factor in this persistent peripheral neuropathic pain. The clinical efficacy of this study will address an exercise protocol post surgery in order to provide an optimal approach in the prevention of scar tissue that may be contributing to persistent pain post microdiscectomy. Mobility and motor control impairments are considered the consequence to the onset of pain. Education, neurodynamics and stabilization exercises are instrumental in the recovery post microdiscectomy with a reduction in pain and disability and the goal towards full functioning. The introduction of a neurodynamic protocol as an early exercise intervention may serve to reduce pain inhibition resulting with improved mobility and motor control. The recording of step count per day following a lumbar microdiscectomy will serve to document daily and physical activity levels following surgery. The purpose of this study is to determine whether or not there is a significant difference in pain levels and lumbar mobility between an early exercise intervention group versus a late exercise intervention group post microdiscectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Uncomplicated unilateral post-op microdiscectomy L3-4, L4-5, L5-S1
  • Radicular symptoms within one year of surgical intervention
  • Ability to understand English or French for instructional purposes
  • Able to participate in physical activity

排除标准

  • Under the age of 18 years or over the age of 65 years
  • Diagnosis of inflammatory conditions such as rheumatoid arthritis, ankylosing spondylitis
  • Metabolic bone disease
  • Cauda equine syndrome
  • Neurological disorders ie Multiple Sclerosis, Parkinsons
  • Compression of the spinal cord
  • Uncontrolled cardiovascular or respiratory disease
  • Peripheral vascular disease with sensory loss in the foot
  • Pregnancy
  • Previous spinal surgeries

研究组 & 干预措施

Early exercise intervention group

Experimental

Education, stabilization and neurodynamic level one exercises will be provided to the intervention group within one to two weeks following a unilateral lumbar microdiscectomy L3-4, L4-5, L5-S1. Within 4-6 weeks, this group will be provided with education, stabilization and neurodynamic level two exercises and a pedometer to monitor step count between week 4 and week 10 following the surgery.

干预措施: Exercise Intervention (Behavioral)

Late exercise intervention group

Active Comparator

Education, stabilization and neurodynamic level one and two exercises will be provided to the active comparator group within 4-6 weeks following a unilateral lumbar microdiscectomy L3-4, L4-5, L5-S1. Within 4-6 weeks, this group will also be given instructions and a pedometer to monitor step count between week 4 and week 10 following the surgery.

干预措施: Exercise Intervention (Behavioral)

结局指标

主要结局

Numeric Pain Rating Scale

时间窗: 3 months

Pain related to low back pain

Patient Specific Functional Scale

时间窗: 3 months

Function related to low back pain

Oswestry Low Back Disability Questionnaire

时间窗: 3 months

Pain and function related to low back pain

Fear Avoidance Beliefs Questionnaire

时间窗: 3 months

Psychological barriers related to low back pain

次要结局

  • Lumbar mobility of flexion and extension(3 months)
  • Slump test mobility(3 months)
  • 50 ft Walk test(3 months)
  • Step count per day(4 weeks)
  • Straight leg raise(3 months)
  • Return to work(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fahad AlKherayf

Neurosurgeon

Ottawa Hospital Research Institute

研究点 (2)

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